by Elizabeth Weise, USA TODAY

by Elizabeth Weise, USA TODAY

Federal drug inspectors found a range of problems, including ineffective drugs given to children and pregnant women, leaky ceilings, insects, non-sterile conditions and at least one bird flying around, at a sister company to the Massachusetts compounding pharmacy linked to a national outbreak of fungal meningitis.

The company, Ameridose, produced injectable drugs. It was founded by the brother-in-law of the man who started the New England Compounding Center, a pharmacy linked to a deadly meningitis outbreak that has killed 32 people and caused 438 illnesses. The cause was contaminated injectable steroids sold by NECC.

At Ameridose, no illnesses have been reported from the problems, dating to 2008, said Sarah Clark-Lynn, a spokeswoman for the Food and Drug Administration.

The agency on Monday released a 20-page inspection report detailing what it found at inspections of the Ameridose plant in Westborough, Mass., which made drugs used to help women in labor, calm children before surgery, treat severe asthma attacks and provide anesthesia during outpatient surgery.

The firm "fails to test finished product for potency, failed to investigate complaints for ineffective products, failed to investigate violations of their own environmental sampling plan and fails to adequately maintain equipment and facilities used to manufacture sterile drug products," Clark-Lynn said.

The company had received 33 complaints claiming "lack of effect" and "ineffectiveness" about its drugs, including medicine used to treat acute asthma attacks and for pain relief, the FDA report said. The same problem was found at the plant in 2008. This was a repeat of a problem found at the problem in a report issued in August of 2008. The FDA is checking what action, if any, the company was required to take in 2008, Clark-Lynn said.

One drug, given to children before medical procedures or surgery to calm them, was found to be ineffective several times despite using the maximum dose, the report said.

When doctors contacted the firm to say that there had been problems with its drugs, the complaints were not classified as adverse events, the report said. That included incidents when women given Ameridose's oxytocin, a drug used to bring on labor, reported fetal distress, severe post-birth post birth bleeding and shortness of breath. A blood thinner, heparin, had a complaint that the patient had a life-threatening adverse event. When the firm's pain medication fentanyl, given to cancer patients and as an anesthetic, was used, two patients were reported to have gone into respiratory distress.

Ameridose is preparing a response, company spokeswoman Krista Robinson said. The company has "not had any instance of contaminated products over the course of the past six years, which covers the manufacture and shipment of 70 million units of product," she said. "Ameridose is committed to addressing all observations in order to enhance our existing systems."

Ameridose voluntarily recalled all its unexpired products in circulation on Oct.31 after FDA inspectors said a preliminary observation of conditions at the facility indicated the firm could not consistently assure that its injectable products were sterile and safe.

At least 58 times, when Ameridose staff found contamination with bacteria and fungi in supposedly sterile liquids used to make up pain relief and anesthetic injections, it didn't investigate, the report said. When testing found that a drug wasn't sterile, no one investigated to see what the "possible root causes of the contamination" were and no "meaningful corrective of preventative actions" were taken, the report said.

Instead, when a test showed a product wasn't sterile, the results "were routinely considered questionable by the laboratory, and retesting was done without justification," the FDA report stated. Initial findings that a given batch wasn't sterile were considered "inconclusive" or "suspect," it said. When further testing was done, "the testing often revealed additional non-sterile units," it said.

Ameridose didn't investigate or take corrective actions at least 45 times when bacteria and mold were found contaminating the manufacturing areas where sterile injectable products were made, the report said.

Ameridose and NECC were founded by brothers-in-law Barry Cadden and Greg Conigliaro. Ameridose says it is a separate entity with separate management.

Since the meningitis outbreak, Cadden, the lead pharmacist at NECC, has resigned from Ameridose.

Contributing: The Associated Press

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